| Device Classification Name |
System, Therapeutic, X-Ray
|
| 510(k) Number |
K882484 |
| Device Name |
CMS RECORD AND VERIFY SYSTEM |
| Applicant |
| Computerized Medical Systems, Inc. |
| 56 Worthington Dr. |
|
Maryland Heights,
MO
63043
|
|
| Applicant Contact |
MELVIN MCCOLLUM |
| Correspondent |
| Computerized Medical Systems, Inc. |
| 56 Worthington Dr. |
|
Maryland Heights,
MO
63043
|
|
| Correspondent Contact |
MELVIN MCCOLLUM |
| Regulation Number | 892.5900 |
| Classification Product Code |
|
| Date Received | 06/15/1988 |
| Decision Date | 12/21/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|